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NCT Number: NCT06617364

MSOT for Assessment of Intestinal Transit Time in Lactose Intolerance Patients

The study aims to investigate gastrointestinal transit using multispectral optoacoustic tomography (MSOT) in a prospective diagnostic study involving patients suspected of primary or secondary lactose intolerance. These patients exhibit varying clinical symptoms and different results from the hydrogen breath test (H2 breath test).

Lactose intolerance is caused by a deficiency in the enzyme lactase, which is responsible for breaking down lactose into glucose and galactose. Without this breakdown, lactose is fermented by colon bacteria, leading to symptoms such as bloating and diarrhea. The prevalence of lactose intolerance is increasing, especially among children, and the current diagnostic gold standard is the hydrogen breath test, which, while specific, has limitations in sensitivity.

MSOT could fill this diagnostic gap by non-invasively measuring intestinal transit time and providing a more objective assessment of the condition.

The study will compare MSOT results with H2 breath test outcomes, particularly focusing on patients with varying disease durations and activity levels.

Additionally, participants are offered an optional MRI examination, which can be used to measure intestinal motility. This helps to further quantify the results of the MSOT examination and discover new findings regarding the extent of the disease.

MSOT could improve the sensitivity of lactose intolerance diagnosis, differentiate it from other conditions, and offer insights into disease management over time.

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Key information

Conditions

Lactose Intolerance Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Erlangen

Erlangen, Bavaria, 91054, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent of the subject
  • Written informed consent of the subject's legal guardian
  • Suspicion or diagnosis of lactose intolerance
  • Age 6 to 18 years

General Exclusion Criteria:

  • Pregnancy
  • Breastfeeding mothers
  • Tattoo in the examination area
  • Subcutaneous fat tissue over 3 cm
  • Known hypersensitivity to ICG, sodium iodide, or iodine
  • Hyperthyroidism, focal or diffuse thyroid autonomy
  • Recent treatment for thyroid function assessment involving radioactive iodine (within two weeks before or after the study)
  • Impaired renal function
  • Use of the following medications: beta-blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite

MRI Exclusion Criteria:

  • General contraindications for MRI examinations (e.g., electrical implants such as pacemakers or infusion pumps, etc.)
  • Severe claustrophobia

Treatment and study plan

gastrointestinal transit time measurement using MSOT and ICG contrast agent

Procedure

The subject arrives at the clinic in the morning, fasting according to the preparation instructions from the Childrens Hospital Erlangen for the H2 breath test. Before taking the liquid containing lactose and ICG, the first measurement is performed using MSOT, followed by the H2 breath test. After the liquid to be detected is fully consumed, the second H2 breath test measurement, which only takes a few minutes, is conducted. According to the official guidelines of the Childrens Hospital Erlangen, the hydrogen concentration in the breath is measured at 30-minute intervals. During the 30-minute breaks, further MSOT measurements are carried out, also at 30-minute intervals. Each of these only takes about 10 minutes, they do not interfere with the H2 breath test measurement routine. After the ninth and final H2 breath test measurement a final MSOT examination is conducted. Afterwards participants are offered an optional MRI examination, which can be used to measure intestinal motility.

Primary outcomes

  1. ICG-Signal in the intestinal tract

    Time frame: 1 day

    measured be MSOT

Secondary outcomes

  1. Hydrogen breath test results

    Time frame: 1 day

    measured in ppm

  2. MRI

    Time frame: 1 day

    peristaltic metrics

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Contrast Enhanced Multispectral Optoacoustic Tomography for Non-invasive Assessment of Intestinal Transit Time in Lactose Intolerance Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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